COPD ExacerbationNCT01917643
Comparative Effectiveness of Symbicort vs. Spiriva Among COPD Patients
An observational study of COPD Exacerbation, run by AstraZeneca.
Trial summary
This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC) and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Exacerbation
- How many people
- 2,396 participants
- Where
- No sites listed yet
- Study dates
- Aug 2013to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Health plan members with COPD aged 40 years or older receiving one or more prescriptions of BFC or tiotropium bromide during 3/1/2009 and 1/31/2012 who are naive to ICS/LABA and LAMA combination therapies.
Who may be able to join
- Continuous health plan enrollment for 12 months before and after index Rx
- At least one prescription fill for BFC or tiotropium bromide during intake period, and naive to ICS/LABA combination or LAMA therapies in year prior to first prescription claim.
- COPD diagnosis, and aged 40 years of age at time of first prescription
- At risk population for COPD exacerbations
Who cannot join
- ICS/LABA combination or LAMA therapy during pre-index period
- Patients with prescription claim for budesonide/formoterol and tiotropium bromide on the same day
- Patients diagnosed with cancer
- Patients with long-term OCS medication use during pre-index period
About this study
Official title: A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol (BFC) and Tiotropium Bromide Among COPD Patients
This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC) and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies.
Read the detailed description
Using US claims data from the HealthCore Integrated Research Environment, COPD patients ≥40 years old initiating BFC or tiotropium between 3/1/2009-2/28/2012 and considered at risk for a future exacerbation were identified and followed for 12 months.
- Conditions
- COPD Exacerbation
- Keywords
- COPD, Comparative Effectiveness, Symbicort
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Symbicort | BFC patients new to ICS/LABA and LAMA therapies | |
| Spiriva | Tiotropium bromide patients new to ICS/LABA and LAMA therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first COPD exacerbation
The time to first COPD exacerbation will be calculated as the date of first COPD exacerbation minus index date. A COPD exacerbation event is defined as any of three conditions: COPD related inpatient hospitalization, COPD related emergency department visit, or COPD outpatient/office visit with a pharmacy claim for OCS and/or antibiotics on the same day or within ten days.
Measured: 12 months
Secondary outcomes (7)
COPD exacerbation rates
The rate of COPD exacerbation will be defined as the total number of COPD exacerbations during the post-index period for all patients in each treatment cohort divided by the total number of person years.
Measured: 12 months
COPD respiratory medication use
Measured: 12 months
COPD related utilization
COPD related outpatient/office visit, COPD related inpatient hospitalization length of stay , COPD related ICU admission and length of stay, COPD procedures.
Measured: 12 months
All-cause utilization
Frequency of all-cause resource use of: inpatient hospitalizations and length of stay, ICU admissions and length of stay, and outpatient/office visits. Total number of different prescription medication classes filled will also be determined.
Measured: 12 months
All-cause and COPD related healthcare costs
Costs will be reported for the following resource uses: inpatient hospitalizations, ED visits, outpatient/office visits, skilled nursing facility, total medical, and prescriptions. Costs will be reported for all-cause as well as COPD related.
Measured: 12 months
Treatment patterns and adherence
Continuity of care during the 12 month post-index period will be measured with the Bice and Boxerman index. Proportion of Days Covered (PDC) and Medication Possession Ration (MPR) will be used to measure the compliance of index medication (Symbicort or Spiriva) during the 12 month post-index period.
Measured: 12 months
Treatment modification
COPD medication use, such as treatment changes, will be captured post-index.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD ExacerbationStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 2,396 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HealthCore, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917643
- Sponsor's protocol ID
- 000202
- Other IDs
- 000202
- Status last verified
- Feb 2016
- First submitted
- 31 Jul 2013
- Last updated
- 3 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A U.S. Retrospective Database Analysis Evaluating the Comparative Effectiveness of Budesonide/Formoterol (BFC) and Tiotropium Bromide Among COPD Patients
- ClinicalTrials.gov ID
- NCT01917643
- Acronym / sponsor ID
- 000202
- Conditions
- COPD Exacerbation
- Keywords
- COPD, Comparative Effectiveness, Symbicort
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,396 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Collaborators
- HealthCore, Inc.
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is intended to evaluate treatment effectiveness with budesonide/formoterol (BFC) and tiotropium tromide in patients new to ICS/LABA combination and LAMA therapies.
Detailed description
Using US claims data from the HealthCore Integrated Research Environment, COPD patients ≥40 years old initiating BFC or tiotropium between 3/1/2009-2/28/2012 and considered at risk for a future exacerbation were identified and followed for 12 months.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symbicort | – | –BFC patients new to ICS/LABA and LAMA therapies |
| Spiriva | – | –Tiotropium bromide patients new to ICS/LABA and LAMA therapies |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Health plan members with COPD aged 40 years or older receiving one or more prescriptions of BFC or tiotropium bromide during 3/1/2009 and 1/31/2012 who are naive to ICS/LABA and LAMA combination therapies.
Key inclusion criteria (4 listed)
- Continuous health plan enrollment for 12 months before and after index Rx
- At least one prescription fill for BFC or tiotropium bromide during intake period, and naive to ICS/LABA combination or LAMA therapies in year prior to first prescription claim.
- COPD diagnosis, and aged 40 years of age at time of first prescription
- At risk population for COPD exacerbations
Key exclusion criteria (4 listed)
- ICS/LABA combination or LAMA therapy during pre-index period
- Patients with prescription claim for budesonide/formoterol and tiotropium bromide on the same day
- Patients diagnosed with cancer
- Patients with long-term OCS medication use during pre-index period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time to first COPD exacerbation
Time frame: 12 months
The time to first COPD exacerbation will be calculated as the date of first COPD exacerbation minus index date. A COPD exacerbation event is defined as any of three conditions: COPD related inpatient hospitalization, COPD related emergency department visit, or COPD outpatient/office visit with a pharmacy claim for OCS and/or antibiotics on the same day or within ten days.
7 secondary outcomes
COPD exacerbation rates
Time frame: 12 months
COPD respiratory medication use
Time frame: 12 months
COPD related utilization
Time frame: 12 months
All-cause utilization
Time frame: 12 months
All-cause and COPD related healthcare costs
Time frame: 12 months
Treatment patterns and adherence
Time frame: 12 months
Treatment modification
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2016.
- Redacted protocol of Study 000202Link provided by the sponsor.
- CSR SynopsisLink provided by the sponsor.
Related trials for COPD Exacerbation
Active, not recruiting
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
COPD Exacerbation, Oxygen Toxicity
Active, not recruiting
FreeDom: Innovative Strategy for the Management of COPD Exacerbations
Oxygen Deficiency, COPD Exacerbation
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Not yet recruitingPhase 1
Investigating Senolytic Properties in Pulmonary Rehabilitation and Metformin in COPD Exacerbations
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingObservational study
Swiss Chronic Obstructive Pulmonary Disease (COPD) Management Cohort
Chronic Obstructive Pulmonary Disease, COPD Exacerbation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD Exacerbation, run by AstraZeneca.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first COPD exacerbation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2016.